Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04268797
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2020-02-07
Brief Title:
TMS in Treatment of Schizophrenia Negative Symptoms
Sponsor:
Sveti Ivan Psychiatric Hospital
Organization:
Sveti Ivan Psychiatric Hospital
Study Overview
Official Title:
Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation With H7-coil in the Treatment of Schizophrenia Negative Symptoms A Multicenter Randomized Sham Controlled Triple Blind Trial
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective to examine the efficacy and safety of high frequency repetitive transcranial magnetic stimulation HF rTMS with H7-coil applied once daily during the twenty days augmentative to the standard antipsychotic pharmacotherapy and other treatment of negative symptoms in schizophrenia
Targeted population patients diagnosed with schizophrenia 18-55 years old with predominant negative symptoms stable condition for 3 months and unchanged antipsychotic therapy for 1 months and no treatment with antidepressants
Study design industry independent multicenter prospective randomized sham-controlled two-arms triple-blind superiority clinical trial with concealed allocation and masked independent outcome assessment
Primary outcome adjusted median of differences in total SANS score Adjustment for age gender baseline total SANS score duration of the disorder and antipsychotic therapy
Targeted population patients diagnosed with schizophrenia 18-55 years old with predominant negative symptoms stable condition for 3 months and unchanged antipsychotic therapy for 1 months and no treatment with antidepressants
Study design industry independent multicenter prospective randomized sham-controlled two-arms triple-blind superiority clinical trial with concealed allocation and masked independent outcome assessment
Primary outcome adjusted median of differences in total SANS score Adjustment for age gender baseline total SANS score duration of the disorder and antipsychotic therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None